NCT02888925

Brief Summary

The purpose is to evaluate neuropsychological effects of anterior temporal epilepsy in face perception by comparison of performances of epileptic patients and control individuals, sex-, age- and socio-educational level-matched. Secondary purposes are to prospectively evaluate neuropsychological impact of anterior temporal lobectomy performed for surgical treatment of anterior temporal epilepsy on face perception (exploratory study).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

4.1 years

First QC Date

August 31, 2016

Last Update Submit

July 23, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Scores obtained with Benton test by patients with anterior temporal epilepsy and matched control individuals

    day 0

Secondary Outcomes (2)

  • Change of scores obtained with Benton test by epilepsy patients before and after lobectomy and control individuals (only patients having undergone anterior temporal lobectomy and matched control individuals)

    day 0 and after 12 to 18 months

  • Change of scores obtained with Benton test by epilepsy patients before and after lobectomy and control individuals (only patients having undergone anterior temporal lobectomy and matched control individuals)

    day 0 and after 24 to 30 months

Study Arms (2)

Epilepsy

OTHER

Patients do face specific tests during conventional pre-lobectomy intercritical assessment hospitalization (inclusion, day 0) and after 6 and 18 months from anterior temporal lobectomy

Other: Mooney testOther: Benton Face Recognition testOther: Face inversion effect testOther: Face composite effect testOther: Cambridge Face Memory TestOther: Matching different view testOther: Memorizing and recognition of new faces testOther: Memorizing and recognition of new objects testOther: Recognition of celebrities and access to semantic information testProcedure: Lobectomy

Control

OTHER

Control individuals do face specific tests during inclusion visit (day 0) and after X months (X = time from day 0 and lobectomy of matched patient + 6 months)

Other: Mooney testOther: Benton Face Recognition testOther: Face inversion effect testOther: Face composite effect testOther: Cambridge Face Memory TestOther: Matching different view testOther: Memorizing and recognition of new faces testOther: Memorizing and recognition of new objects testOther: Recognition of celebrities and access to semantic information test

Interventions

ControlEpilepsy
ControlEpilepsy
ControlEpilepsy
ControlEpilepsy
ControlEpilepsy
ControlEpilepsy
LobectomyPROCEDURE

In patients with anterior temporal epilepsy, at 6 to 12 months after inclusion, depending on surgery decision taken after pre-surgery conventional intercritical assessment

Epilepsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ALL:
  • Informed consent
  • Affiliation to social security
  • Preliminary medical examination
  • PATIENTS WITH EPILEPSY:
  • Symptomatic drug-resistant anterior temporal epilepsy (confirmed with video-electroencephalography and magnetic resonance imaging and if necessary intracerebral SEEG exploration)
  • Patient needing anterior temporal lobectomy and undergoing pre-surgery conventional intercritical assessment for surgery decision
  • Nonverbal IQ ≥ 70 (WAIS-IV)
  • At least 6 successful VOSP tests (perception test)

You may not qualify if:

  • ALL:
  • persons under legal protection or incapable to consent
  • Persons deprived of liberty by juridical or administrative decision
  • PATIENTS WITH EPILEPSY:
  • \- Sever visual disorders of neurological or ophthalmological origin
  • CONTROL INDIVIDUALS:
  • Psychiatric or neurological disorders
  • Important ophthalmological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Neurologie, Hôpital Central, CHU de Nancy

Nancy, France

Location

MeSH Terms

Interventions

Anterior Temporal Lobectomy

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeNeurosurgical Procedures

Study Officials

  • Louis Maillard

    Service de Neurologie, Hôpital Central, CHU de Nancy, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 5, 2016

Study Start

August 1, 2013

Primary Completion

September 1, 2017

Study Completion

March 1, 2020

Last Updated

July 24, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations